4 ms·

Another point of interest: https://www.the-rheumatologist.org/article/the-unapproved-drugs-initiative-is-coming-to-an-end/ https://www.the-rheumatologist.org/a

Another point of interest: https://www.the-rheumatologist.org/article/the-unapproved-drugs-initiative-is-coming-to-an-end/ https://www.the-rheumatologist.org/article/the-unapproved-dr... On Friday, Nov. 20, 2020, the U.S. Department of Health and Human Services (HHS) published a Notice through the Federal Register announcing the withdrawal of guidance documents that established the Unapproved Drugs Initiative. This Notice brings to an end a 14-year-old program that has been blamed for significantly contributing to the rising cost. So... again, yes... greed.

refurb 5y ago
Trying to get unapproved drugs through the FDA approval process is greed?
- cityzen 5y ago
  you're either trolling or lazy... here's an excerpt from the article: In total, 34 previously unapproved drugs were addressed through the Unapproved Drugs Initiative. In a 2017 analysis, researchers found that 90% of those drugs were approved through the new drug application 505(b)(2) pathway.2 The 505(b)(2) pathway does not require new clinical trial evidence and can be based on literature reviews or bioequivalence studies alone. New market exclusivity for these drugs led to a median price increase of 37% (interquartile range [IQR] = 23–204%) within two years of approval. It also resulted in more supply shortages of these drugs after approval, and these shortages also lasted longer likely because of the exclusivity. it's greed my friend.
  - refurb 5y ago
    How is it greed that someone goes through the process of getting FDA approval (which is more than just running trials), sets up FDA approved manufacturing, does all the monitoring, etc, then charges for it? You realize the application fee alone for 505(b)(2) is $1.6M?[1] It's not like someone just emails a few papers with an application form to the FDA and gets FDA approval. [1]https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments https://www.fda.gov/industry/fda-user-fee-programs/prescript...

refurb 5y ago

Trying to get unapproved drugs through the FDA approval process is greed?

cityzen 5y ago
you're either trolling or lazy... here's an excerpt from the article: In total, 34 previously unapproved drugs were addressed through the Unapproved Drugs Initiative. In a 2017 analysis, researchers found that 90% of those drugs were approved through the new drug application 505(b)(2) pathway.2 The 505(b)(2) pathway does not require new clinical trial evidence and can be based on literature reviews or bioequivalence studies alone. New market exclusivity for these drugs led to a median price increase of 37% (interquartile range [IQR] = 23–204%) within two years of approval. It also resulted in more supply shortages of these drugs after approval, and these shortages also lasted longer likely because of the exclusivity. it's greed my friend.
- refurb 5y ago
  How is it greed that someone goes through the process of getting FDA approval (which is more than just running trials), sets up FDA approved manufacturing, does all the monitoring, etc, then charges for it? You realize the application fee alone for 505(b)(2) is $1.6M?[1] It's not like someone just emails a few papers with an application form to the FDA and gets FDA approval. [1]https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments https://www.fda.gov/industry/fda-user-fee-programs/prescript...